NCT07261592Not yet recruitingPhase 1/2
Entinostat & Chemotherapy for Locally Advanced or Metastatic Bladder Cancer
Entinostat Combined With Chemotherapy as Second-line Therapy for Unresectable Locally Advanced or Metastatic Bladder Cancer: A Single-arm, Prospective Clinical Trial
Source: ClinicalTrials.gov · Last updated 3 Dec 2025
Brief summary (registry, in English)
This single-center single-arm, open-label prospective clinical trial aimed to evaluate the efficacy and safety of entinostat combined with chemotherapy as second-line therapy for unresectable locally advanced or metastatic bladder cancer.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 29 (estimated)
- First submitted
- 22 Nov 2025
- Start date
- 1 Dec 2025
- Primary completion date
- 30 Sept 2028
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Diseases
- Bladder cancer
- NCT number
- NCT07261592
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 29
- From 1 Dec 2025 to the primary completion date, 30 Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who received platinum-based chemotherapy after failure of first-line treatment;
- Patients who received platinum-based chemotherapy withnin a 24 month before this trial;
- Those who have received other anti-tumor treatment or participated in other clinical studies within 4 weeks before the start of the study, or have not recovered from the last toxicity (except grade 2 hair loss and grade 1 neurotoxicity);
- Concomitant disease such as uncontrolled hypertension or diabetes, renal inadequacy, myocardial infarction, severe angina;
Other illness
- Patients with serious physical or mental illnesses.
Other
- Female subjects who are pregnant, breastfeeding or planning to become pregnant during the study;
Who the study is looking for
- Histopathologic confirmed unresectable advanced or metastatic bladder cancer, except for those with squamous differentiation, glandular differentiation or both;
- Failure of first-line treatment;
- There is at least one measurable lesion according to RECIST 1.1;
- Archived tumor tissue samples or tumor biopsies must be provided;
- ECOG score of 0-1 an an estimated survival of at least 6 months;
- Adequate organ function;
- Patients voluntarily participated in this study, signed the informed consent form, and had good compliance;
- Women with fertility must consent to contraception during the study and for 6 months after the last dose of study drug.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.